Tag: brand safety-nsf health issues

Texas abortion drug ruling could create ‘slippery slope’ for FDA approvals, drug research and patients, experts say | CNN

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CNN
 — 

What happened in one judge’s courtroom in Texas could have drastic effects for the United States’ entire drug approval process, experts warn.

US District Judge Matthew Kacsmaryk’s ruling that suspended the US Food and Drug Administration’s approval of the medication abortion drug mifepristone was an unprecedented one, the first time a court has bypassed the federal system set up to determine what drugs should be allowed on the market.

Regardless of whether the ruling – or a part of it – is ultimately allowed to stand, legal scholars, scientists and drugmakers are concerned that the decision could start a trend of drugs being targeted in courts, creating a chilling effect on drug development in the US and hurting patients in the process.

Vaccines, including the Covid-19 shots, antidepressants and psychotropic medicines could be at risk, some said.

“Well, one does not want to be Chicken Little,” former FDA Commissioner Dr. Jane Henney said Wednesday, but “I can’t imagine that it wouldn’t have implications for other products.

“The approval process will be at risk, and it’s not just an approval process that patients rely on and providers rely on, it’s one that has been considered the gold standard, really, for the world,” said Henney, who was the head of the FDA when mifepristone was approved.

Since the dawn of the 20th century, the FDA has had the sole authority in the United States to regulate drugs. In 1906, the federal government created the agency to enforce the Pure Food and Drug Act, which was instituted to ensure that medicine, food and cosmetics were safe.

Over the years, that authority became more defined.

After elixir of sulfanilamide, a drug used to treat streptococcal infections, killed 107 people in 1937, Congress created the Food, Drug, and Cosmetic Act. Signed into law in 1938 by President Franklin D. Roosevelt, it required manufacturers to conduct pharmacological studies to prove that their drugs were safe before they could be sold or advertised. In 1962, drug manufacturers were also required to prove to the FDA that their products were effective.

Modern drug approval in the US is a careful and conscientious process. Before any drug goes to market, there are countless hours of research, the work and expertise of multiple scientists, and several layers of oversight for approval.

Until now, the courts have been deferential to the FDA’s process and have never overturned an FDA decision on the grounds that the agency misjudged the science, said William Schultz, a former deputy commissioner at the FDA and former general counsel for the Department of Health and Human Services.

“Any FDA drug approval involves hundreds of judgments by the agency. And if a court feels free just to kind of take a fresh look at each of those, there’s a chance that a court will find one of those FDA judgments wrong,” Schultz said in an online discussion Monday about the impact of the Texas court’s ruling that was hosted by Protect Our Care, an organization that advocates for equitable and affordable health care.

Hundreds of well-known biotech and pharmaceutical company leaders, concerned about the effects of Kacsmaryk’s ruling on other drug approvals, signed an open letter Monday in support of the FDA’s authority “to approve and regulate safe, effective medicines for every American.”

The letter also advocated a reversal of the mifepristone decision from a judge with “no scientific training,” saying it “set a precedent for diminishing FDA’s authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry.”

In a separate statement, the biotech industry group BIO’s interim president and CEO, Rachel King, emphasized the “dangerous precedent” the decision sets.

“The preliminary ruling by a federal judge in Texas is an assault on science and the FDA’s long-standing role as the authority to make decisions on the safety and efficacy of medicines. For a court to invalidate the approval of a drug that was reviewed and approved more than two decades ago is without precedent. As legal scholars have noted, the courts do not have the medical expertise to make these types of scientific determinations,” King said.

The main lobbying group for the pharmaceutical industry, PhRMA, criticized Kacsmaryk’s ruling as undermining the regulatory process.

“PhRMA has serious concerns with any court substituting its opinion for the FDA’s expert approval decision-making,” said James C. Stansel, the association’s executive vice president, general counsel and corporate secretary. Stansel added that such a decision could have a “chilling effect on the research and development ecosystem.”

The pharmacutical sector is a huge part of the American economy. Of the world’s 25 largest phamacutical companies, 10 are based in the US, and most of the others have a large base of operations in the country.

Often, the US market is the first to get access to new drugs, but that could change if lawsuits undermine the regulatory integrity of the FDA process, said Susan Lee, partner in the law firm Goodwin’s Life Sciences group and Life Sciences Regulatory & Compliance practice, who works with companies to get drugs approved by the FDA.

“If there do tend to be more lawsuits like this, I wonder if there might be a little bit of a tendency to not always look at the US as the first market,” Lee said. “Some manufacturers may say ‘we’d rather go to Europe, where we’re not going to be sued on a jurisdiction-by-jurisdiction basis.’ “

Lee also wonders whether manufacturers will abandon efforts to develop drugs that could be considered unappealing to some, such as those that help women’s health or work to prevent HIV.

“I think there are just certain sectors that are already kind of thinking about whether they might also have a target on their back. I’ve definitely heard that discussed,” Lee said.

The groups at the heart of the Texas case have not disclosed any further plans regarding lawsuits over medications, but experts say they are already hearing concern.

“I’ve already been getting questions from lawmakers and other people about ‘could the Covid vaccine be next?’ or other things that may have stigma around it,” said Dr. Kristyn Brandi, an ob/gyn and abortion provider in New Jersey and a spokesperson for the American College of Obstetricians and Gynecologists.

The Covid-19 vaccines have been thoroughly tested and found to be safe and effective, but they’re the subject of conspiracy theories and misunderstanding about how mRNA vaccines were tested. Beliefs that the vaccines were tested on recently harvested aborted fetal cells made some people decidedly anti-vaccine.

Dr. Lynn R. Goldman, professor and dean of the Milken Institute School of Public Health at George Washington University, is also concerned that mRNA vaccines could be targeted soon.

“There might be people who disagree with some of the technologies that are used by vaccine makers, like the mRNA vaccines, but feeling uncomfortable about a technology is not the same thing as identifying that there is risk,” she said in the Protect Our Care conversation.

Members of the LGBTQ+ community may also be vulnerable, experts say, as activists could target puberty blockers or hormones used in gender-affirming therapy.

“I don’t like to do slippery slope, but I’m also very worried about things like gender-affirming care, since there’s already been so many laws about that recently in other states,” Brandi said.

There is political pressure against other vaccines, antidepressants and psychotropic medicines, among others, former FDA Commissioner Margaret Hamburg and former Principal Deputy Commissioner Joshua Sharfstein wrote in an editorial published Thursday in the journal Science.

“If judges begin to dictate the terms of medication access, then others will seek to use ideology and influence to advance their agendas,” they warn.

Goldman said that any legal decision that could undermine the FDA drug approval process would ultimately hurt the doctors who prescribe them and the people who use them.

Doctors don’t have time to vet all the studies used to prove that a drug is safe and effective, so they rely on the FDA for this work, she said. Court interference could confuse this process.

“I think that this is, for doctors, an incredibly serious moment, because up to now, we have been able to trust that an approval by the FDA is a science-based decision and that we can say that if the FDA has approved a drug, that it is safe for us to use,” Goldman said.

A lack of confidence in the drug approval process will ultimately hurt people far beyond the most recent decision, Protect Our Care Chair Leslie Dach says.

“Confidence that the FDA can do its work is essential for clinicians and patients who depend on it in its decision-making for matters of life and death,” Dach said.

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‘Big step forward’: New lab tests may accelerate Parkinson’s diagnosis and research | CNN

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CNN
 — 

A lab test that can tell doctors if someone has Parkinson’s disease is a long-sought goal of researchers.

Doctors currently diagnose the progressive condition by looking for telltale physical symptoms: tremors, a halting gait, stiffness or trouble balancing. About 90,000 Americans are diagnosed on the basis of these symptoms each year, according to a recent study.

These signs can be subtle at first, and it can be difficult to discriminate Parkinson’s from other disorders until the disease is more advanced and affects more of the brain.

The lack of a lab test that can pick up the disease in its early stages has also stymied the search for new treatments. Studying a group of people with the same movement symptoms could mean inadvertently including those whose condition could be caused by something else.

It also means people are usually studied when the disease process is well under way. Many therapies work best when they’re given at the first sign of symptoms, or even before.

All this may soon change, thanks to new tests that are able to detect traces of a key protein that misfolds and gums up specific areas of the brain, called alpha-synuclein.

One test, SYNTap, which looks for seeds of this misfolded protein in spinal fluid, was just vetted in the Parkinson’s Progression Marker’s Initiative, a large study undertaken by the Michael J. Fox Foundation. Several companies are developing versions of this type of test.

It joins another test called Syn-One, which detects traces of the protein in skin. Syn-One has been available since 2019 and is being studied with funding from the National Institutes of Health.

When they return positive results, the new tests don’t diagnose Parkinson’s disease but rather point to a group of disorders caused by abnormal clumping of the alpha-synuclein protein. Those include dementia with Lewy bodies and multiple system atrophy, a rare disorder that causes damage to several areas of the brain. Parkinson’s is the most common of these disorders.

Parkinson’s affects the nervous system and, in addition to movement-related symptoms, can cause problems such as depression, anxiety, cognitive impairment, trouble sleeping, hallucinations and loss of smell. It’s not fatal, but it can have serious complications. The exact cause is largely unknown.

The tests usher in “a bit of a new chapter for us in Parkinson’s disease, where we can really focus on biology,” said Dr. Kathleen Poston, a professor of neurology and neurological sciences at Stanford University, who participated in a study of the SYNTap test.

“I think that will very hasten our engagement and clinical trials and, I hope, allow us to have more successful therapeutic clinical trials in in the next five years,” Poston said.

The test is available to doctors, but it had not been shown to be reliable in a large clinical trial.

In a study published Wednesday in the journal Lancet Neurology, the SYNTap test proved to be accurate when given to 1,100 participants, including people with Parkinson’s, people with genetic or clinical risk factors who had not been diagnosed, and healthy controls. Overall, the test correctly identified people with Parkinson’s disease 88% of the time and correctly ruled it out 96% of the time.

“It shows that this method is fairly accurate for detecting Parkinson’s disease, even in patients who do not yet have symptoms,” said Dr. Andrew Ko, a neurosurgeon at the University of Washington School of Medicine who was not involved in the research. “This is a big step forward showing that this type of test is accurate.”

The test was most accurate in people without any known genetic risks for Parkinson’s disease, who also had loss of their sense of smell. In this group, the test correctly detected the disease 99% of the time. If they didn’t have a loss of smell, the accuracy dropped to 78%.

In people with the most common genetic risk, a mutation in their LRRK2 gene, the test correctly flagged Parkinson’s only about 67% of the time.

That means the test is very good at ruling out Parkinson’s, but it will miss some people who actually do have it.

“If you had this test and it was ‘normal’ or negative … it doesn’t mean you don’t have Parkinson’s disease,” said Dr. Kelly Mills, a neurologist and director of the Movement Disorders Division at Johns Hopkins University, who was not involved in the research.

For the time being, that means the test itself won’t be so helpful to individual patients.

“I think it’s a big deal for research, which is going to be a huge deal for patients,” Mills said.

The study’s authors agree.

“Right now, the test has sort of only a modest utility in routine clinical care,” said study author Dr. Andrew Siderowf, a neurologist at the University of Pennsylvania’s Perlman School of Medicine.

Parkinson’s treatment is based on relieving symptoms, and all the test can do is to help a doctor refine a diagnosis. It won’t change how a patient is treated, but it might bring some people peace of mind that their diagnosis is correct, Siderowf said.

It’s also a very invasive test that requires a painful procedure called a spinal tap, although researchers hope to soon translate their results to other kind of biological samples, such as blood or saliva, that would be easier to collect.

One of the most promising results of the study was in people who had early changes that are known to be strongly tied to the development of Parkinson’s disease. In 18 people who had lost their sense of smell, the test detected alpha-synuclein in 16. In another group of 33 people with REM sleep behavior disorder, which makes people kick, punch or hit in their sleep as they act out their dreams, the test detected alpha-synuclein in 28.

Because this group was so small, the researchers say, those tests will have to be repeated to learn whether it can detect the disease before movement is impaired.

But that is the goal, according to the study’s funders at the Michael J. Fox Foundation, who believe that this test will revolutionize research.

“We have a really robust current pipeline of therapeutics that are looking to interfere with the the biology and the disease,” said Deborah Brooks, CEO of the foundation. “We will continue at a rapid and aggressive pace,” she said.

Brooks said that when they learned the results of the SYNTap tests, she flew out to see actor and philanthropist Fox, who was vacationing with his family, to tell him personally. Fox has been living with Parkinson’s since 1991.

Together, they called one of the foundation’s scientists, Dr. Todd Sherer, a neuroscientist who is also the foundation’s chief mission officer.

“I said, ‘so, you know, Todd’s calling in, but he’s gonna tell you all the details. I’m just gonna give you the headline: We’ve had a breakthrough,’ ” Brooks said.

Fox and Sherer had been searching for a biomarker for the condition for over a decade.

When Sherer finished his presentation, Brooks said, Fox leaned over, picked up the laptop and kissed him on the head.

“This is awesome,” he said.

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When children are told they were born via assisted reproduction can affect outcomes, study finds | CNN

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CNN
 — 

At age 14, Helen wasn’t bothered by the fact she was born via surrogacy.

“My mum is still my mum. My dad is still my dad,” she told UK researchers conducting a study on the mental health and well-being of children born through egg donation, sperm donation and surrogacy. Helen is not her real name.

“I was talking to someone at school and they said they were an accident,” 14-year-old Simon (also not his real name) told the researchers. “I know I was no accident, I was really wanted, and it makes me feel special.”

Parents worried their children may experience difficulties as a result of learning they were conceived by assisted reproduction can stop fretting — the kids are just fine, according to the study published this week after two decades in the making.

“When we began this study more than 20 years ago, there was concern the absence of a biological link between the child and the parents could have a damaging effect on their relationship and on the well-being of the child,” said lead author Susan Golombok, professor emerita of family research and former director of the Centre for Family Research at the University of Cambridge in the UK.

However, at age 20, children born via egg or sperm donation and surrogacy were psychologically well-adjusted, the study found, especially if parents told the children about their birth history before age 7.

“What this research means is that having children in different or new ways doesn’t actually interfere with how families function. Really wanting children seems to trump everything — that’s what really matters,” Golombok said.

Clinical psychologist Mary Riddle, an associate professor of psychology at Pennsylvania State University called the study “important, in that it represents research conducted over a long period of time.”

However, Riddle, who was not involved in the study, said the results aren’t completely applicable to the United States because surrogacy can be practiced differently in the UK in several ways.

Called “tummy mummies” by some of the children, surrogates in the UK may become part of the family, participating in the upbringing of the child they helped bring into the world, according to Golombok’s 2020 book, “We Are Family: The Modern Transformation of Parents and Children.”

“In the UK, intended parents often know their surrogate prior to the surrogate pregnancy whereas in the US, commercial surrogates are often matched through agencies and don’t have prior relationships with the families for whom they carry babies,” Riddle said.

It’s also more common in the UK to use “partial” surrogacy, in which surrogates are impregnated with the sperm of the intended father and are therefore the biological mother of the child, Riddle said.

“Here in the US, gestational surrogacy, where the surrogate mother has no genetic connection to the child she is carrying, is far more common and thought to be potentially less fraught with psychological and legal pitfalls,” she added.

The study, published Wednesday in the journal Developmental Psychology, followed 65 children — 22 born by surrogacy, 17 by egg donation and 26 by sperm donation — from infancy until age 20. Another 52 families who did not use any assistance were also followed. Researchers spoke to the families when the children were 1, 2, 3, 7, 10 and 14.

Young adults who learned about their biological origins before age 7 reported better relationships with their mothers, and their mothers had lower levels of anxiety and depression, the study found.

However, children born through surrogacy had some relationship issues around age 7, “which seemed to be related to their increased understanding of surrogacy at that age,” Golombok said.

“We visited the families when the children were 10, and these difficulties had disappeared,” she said. “Interestingly, the same phenomenon has been found among internationally adopted children. It may have to do with having to confront issues of identity at a younger age than other children.”

Developmentally, children begin to notice and ask questions about pregnancy between the ages of 3 and 4, said clinical psychologist Rebecca Berry, an adjunct faculty member in the department of child and adolescent psychiatry at New York University’s Grossman School of Medicine.

“To satisfy their curiosity they’ll begin to ask questions about babies and where they came from as a way of trying to understand why they are here,” said Berry, who was not involved with the study.

Children as young as 7 will already have a basic understanding of genetics, and can be surprised when they learn they aren’t genetically connected to one or both parents, said Lauri Pasch, a psychology professor at the University of California San Francisco, who specializes in infertility and family building.

“Our current thinking is that it is best for parents to share the story of donor conception with their children at a very early age, so that if I were to ask their child when they are an adult when they learned that they were donor conceived, they would respond that they ‘always knew,’” said Pasch, who was also not involved in the study, via email.

“This allows the child to grow up with the information, as opposed to learning it later in life, when it comes as a surprise or shock and can hurt their trust in their parents and their identity development,” she added.

When it came to maternal anxiety and depression, there were no differences between families formed by surrogacy and egg or sperm donation and families with children born without assisted conception. Nor were they any differences in the mothers’ relationships with their partners at home, the study found.

However, mothers who had babies via donor eggs reported less positive family relationships than mothers who used sperm donation, likely due to insecurities about lack of a genetic connection to their children, Golombok said.

Young adults conceived by sperm donation reported poorer family communication than those conceived by egg donation, the study found. That’s perhaps due to a greater reluctance on the part of fathers to disclose they are not a genetic parent, Golombok said.

Only 42% of parents who had conceived via sperm donor had revealed the child’s birth history by the time their children were age 20, compared to 88% of egg donation parents and 100% of parents who used surrogacy.

When asked, many of the children said they weren’t concerned about how they were conceived.

“A lot of the children said ‘It’s not a big deal. I’ve got more interesting things going on in my life,’ while others said ‘Actually it’s something a bit special about me. I like talking about it,’ Golombok said. “I think it’s really nice to hear from the children themselves and I don’t think any other study has done this.”

Once told, a child needs to revisit the birth history from time to time, so parents should be sure any conversation is an ongoing one, Golombok said.

“There is this idea parents will tell the child and that is it. But you need to keep having these conversations to give the child a chance to ask questions in an age appropriate way as they grow older,” she said.

“Many of the parents in our study use children’s books that were specifically designed for this purpose,” Golombok added. “Then they could bring the child’s own story into the narrative.”

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Biden administration declares fentanyl laced with xylazine ‘an emerging threat’ in the US | CNN

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CNN
 — 

The White House has declared that the powerful synthetic opioid fentanyl combined with xylazine – an animal tranquilizer that’s increasingly being used in illicit drugs – is an “emerging threat” facing the United States due to its role in the ongoing opioid crisis.

Administration officials call the threat FAAX, for fentanyl-adulterated or -associated xylazine.

The move, announced Wednesday, marks the first time in history that any administration has declared a substance to be an emerging threat to the country, said Dr. Rahul Gupta, director of the Office of National Drug Control Policy. The SUPPORT Act of 2018 established that the office has authority to declare such “emerging threats,” and no administration has used it until now. Last year, Congress declared methamphetamine an emerging drug threat but none have been declared by an administration previously. Under other agencies or in separate circumstances, concerns such as bioterrorism, infectious diseases or climate change may be identified as “emerging threats.”

“This drug, which is an animal sedative, is being mixed with fentanyl and is being found in almost all 50 states now,” Gupta said Tuesday. “It’s become an important part for us to make sure that we’re declaring it an emerging threat.”

Now that the administration has declared fentanyl combined with xylazine an emerging threat, it has 90 days to coordinate a national response. “We are working quickly to develop and implement a whole of government nationwide plan, with real deliverable action, that will save lives and will be published within 90 days of this designation,” Gupta said.

Xylazine, also known as tranq or tranq dope, has been linked to an increasing number of overdose deaths in the United States due to its rising illicit use. Between 2020 and 2021, overdose deaths involving xylazine increased more than 1,000% in the South, 750% in the West and about 500% in the Midwest, according to an intelligence report released last year by the US Drug Enforcement Administration.

And in some cases, people might not even know that xylazine was in the drug they used.

Just last month, authorities at the DEA issued a public safety alert about the “widespread threat” of fentanyl mixed with xylazine, reporting that in 2022 approximately 23% of fentanyl powder and 7% of fentanyl pills seized by the DEA contained xylazine.

Fentanyl, which has been driving the opioid crisis, is a fast-acting opioid, and people who use it illicitly say that adding xylazine can extend the duration of the high the drug provides.

Xylazine is not an opioid. It is approved by the US Food and Drug Administration for use as a tranquilizer in veterinary medicine, typically in horses, but it is not approved for use in humans. And xylazine can do major damage to the human body, including leaving drug users with severe skin ulcers, soft-tissue wounds and necrosis – sometimes described as rotting skin – that can lead to amputation.

“Xylazine is one of the contaminants in fentanyl, but there could be others,” Gupta said. “So, I think with the declaration of an emerging threat, we’re sending a clear message to producers and traffickers of illicit xylazine and illicit fentanyl that we’re going to respond quicker, we’re going to match the challenge of evolution of these drugs supply, and that we’re going to protect lives first and foremost.”

Now that xylazine has been declared an emerging threat, some of President Biden’s $46 billion drug budget request to Congress can be used to respond.

This year, the Biden administration announced that the President has called on Congress to invest $46.1 billion for agencies overseen by the Office of National Drug Control Policy to tackle the nation’s illicit drug crisis.

If the budget request is not approved, there could be the option to reallocate money within the Office of National Drug Control Policy, but “we don’t want to be in a position where moneys that are being utilized for some other important aspect of saving lives has to be moved away for this purpose,” Gupta said Tuesday. “That is the reason we are asking Congress to act.”

Such funds could be used to test drugs on the street for xylazine, collect data on FAAX, invest in care for people exposed to FAAX and develop potential treatments for a xylazine-related overdose.

The medication naloxone, also known as Narcan, is an antidote for an opioid overdose, but people who have overdosed on a combination of opioids and xylazine may not immediately wake up after taking naloxone, as it may not reverse the effects of xylazine in the same way it does opioids.

“We need to recognize, first of all, that there is a shift that is occurring from organic compounds and substances like heroin and cocaine to more synthetics,” Gupta said of the state of the nation’s illicit drug crisis.

“Both the types of drugs have changed – from predominantly organic to predominantly synthetics – but the way drugs are bought and sold have also changed,” he said. “Now, all you need is a phone in the palm of your hand and a social media app to order and buy some of the most dangerous substances on planet Earth.”

Xylazine is just one of the many adulterants – or substances that are typically added to others – found in the nation’s illicit drug supply.

“All of a sudden, you can synthesize hundreds of compounds and kind of mix them together and see what does the best in the market,” Joseph Friedman, a researcher at the University of California, Los Angeles, told CNN in March. “People are synthesizing new benzodiazepines, new stimulants, new cannabinoids constantly and adding them into the drug supply. So people have no idea what they’re buying and what they’re consuming.”

Some of these adulterants may be as simple as sugar or artificial sweeteners added for taste or additives or fillers that bulk up the drug. Sometimes, they may be contaminants left over from the manufacturing process.

Addicted? How to get help

  • If you’re addicted to prescription drugs, help is available. You can call the Substance Abuse Mental Health Services Administration 24/7 hotline at 1-800-662-HELP(4357) or visit their website.

    • But all of these things can carry real-life health harms, says Naburan Dasgupta, an epidemiologist and senior scientist at the Gillings School of Global Public Health at the University of North Carolina, Chapel Hill.

    Like an opioid, xylazine can depress the respiratory system, so the risk of overdose multiplies when it’s combined with heroin or fentanyl.

    Also, “in the veterinary literature, we know that it causes a really bad severe form of anemia. And so when people are injecting heroin that’s contaminated with xylazine, they can end up with a near-fatal form of blood iron deficiency,” Dasgupta said in March. “We had one person here who ended up going to the hospital needing multiple blood transfusions. And it was all because of the xylazine.”

    US lawmakers are moving to classify xylazine as a controlled substance.

    In March, bipartisan legislation – the Combating Illicit Xylazine Act – was introduced in the House and Senate. It describes illicit xylazine as an “urgent threat to public health and safety” and calls for it to be a Schedule III drug under the Controlled Substances Act, a category on the five-level system for substances with moderate to low potential for physical or psychological dependence. Xylazine would be one level below opioids like fentanyl.

    “Our bipartisan bill would take important steps to combat the abuse of xylazine by giving law enforcement more authority to crack down on the illicit distribution of this drug, including by putting stiffer penalties on criminals who are spreading this drug to our communities,” Sen. Maggie Hassan, D-N.H., said in a statement in March.

    The bill would also require manufacturers to send reports on production and distribution to the DEA so the agency can ensure that the product is not being diverted to the black market.

    “This bill recognizes the dangers posed by the increasing abuse of animal tranquilizers by drug traffickers, and provides new tools to combat this deadly trend,” Sen. Chuck Grassley, R-Iowa, said in the statement.

    “It also ensures that folks like veterinarians, ranchers and cattlemen can continue to access these drugs for bona fide animal treatment.”

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    What is autism? An expert explains | CNN

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    CNN
     — 

    Some individuals with autism have challenges processing senses. Others struggle to communicate. Still others might have a tough time socializing, thinking, physically moving or just going about daily living.

    People with autism have their own ways of interacting with the world, because autism is a developmental disability that affects everyone who has it a little differently, according to Dr. Daniel Geschwind, the Gordon and Virginia Macdonald distinguished professor of human genetics, neurology and psychiatry at UCLA.

    Geschwind has spent 25 years studying autism and what causes it. To mark Autism Awareness Month, CNN talked with him about what autism is and what causes it.

    This conversation has been lightly edited and condensed for clarity.

    CNN: What is autism?

    Dr. Daniel Geschwind: Autism refers to a broad range of conditions characterized by challenges with social skills and social and communication and repetitive behaviors, resistance to changes in routine, or restricted interests. I prefer to call it “the Autisms,” because it’s not one thing, and no two autistic children or adults are exactly alike even though they may share basic features. People with autism may also have some sensory-motor integration issues, especially sensory hypersensitivity.

    CNN: How prevalent is autism today?

    Geschwind: It isn’t rare. The most recent statistics (from the US Centers for Disease Control and Prevention) came out in March, pulled data from 11 sites (in the United States) and reported 1 out of every 36 kids is autistic. The study before that estimated around 1 in 40. About 10 years ago, the autism rate was 1 in 100, or even lower.

    It would be easy to look at this trend and say autism is increasing, but that’s not really what is happening. The most recent data reflects that our ability to recognize autism and diagnose it early has improved dramatically. We’re now able to diagnose people with autism who might have (previously) fallen through the cracks.

    Everybody is neurodivergent to some extent. For example, if you look at a simple IQ test, a substantial portion of people will perform really badly on one specific item. That doesn’t mean they have problems — it’s just that it means we all have strengths and weaknesses.

    If I were being tested on artistic ability, for example, or engineering ability, I would be far below what’s called typical. I think we have to accept that intelligence is not just one thing, that cognition isn’t one thing, that there’s not just one way to behave.

    CNN: What does it mean when people describe some as being “on the spectrum”?

    Geschwind: About a decade ago, the term “autism spectrum disorder” was adopted to encompass everything that we called autism into one rubric. The intent was simply to describe the variability in how people with autism act and behave biomedically. There are some autistic individuals who just need accommodations and don’t need treatment. There are other autistic individuals who need a lot of treatment. The spectrum was intended to include them all.

    Over time, non-autistic people began referring to the spectrum in a linear fashion: high to low. That means some autistic individuals were categorized as “high-functioning,” while others were categorized as “low-functioning.” For many, the notion of a spectrum is now a loaded term. Many believe that instead of talking about autism in a linear fashion, we should talk about it as a wheel or pie, where each slice represents a different trait and every individual has different strengths and weaknesses.

    CNN: Is there a cure for autism?

    Geschwind: There is no cure. At the same time, we’ve come very far in understanding what autism is, and we’re making progress on how to treat it. When I started researching autism 25 years ago, the autism rate was 1 in 1,000 or 1 in 2,000. To put it in deeper historical perspective, I think at that time there was only about $10 million a year or less in autism research being done that was funded (by the National Institutes of Health). And so, there was a huge disconnect between the research dollars, public awareness and the real needs of patients and families.

    The notion of the term “curing” autism can be controversial. From my perspective, our true goal is to establish a kind of personalized medicine, or precision health in autism and other neuropsychiatric disorders, so that each autistic person is seen as the individual they are. We envision a world where individuals who are severely impacted by autism have the opportunity to get therapy and drugs that can help them — and those for whom a therapy is not warranted or who don’t want it will have opportunities to live life the way they want to as well. Patient autonomy and societal accommodation are important aspects when considering these issues.

    CNN: What causes autism?

    Geschwind: Almost every medical condition has both genetic and environmental components. In autism, it seems that heritability is very high. The most recent large study suggested that heritable genetic factors — the things that you get from your parents that your parents have in their DNA — are probably somewhere around 80% or slightly higher.

    That leaves 20% that’s nonheritable, and of that we know that at least 10% of autism is caused by rare mutations that are not inherited. And that sounds like a paradox, but it’s not. If you think about Down syndrome, that’s a genetic mutation that the parents don’t have in their DNA. That’s called a new, or de novo, mutation.

    You can calculate a risk score for having autism based on genetics, (but) right now, the risk score for autism is not that predictive because we haven’t done enough research. For other conditions like cardiovascular or certain cancers, risk scores are very predictive because very large numbers of people have been studied.

    Even so, this autism risk score is strongly correlated with high educational attainment, or a high IQ, which again speaks to the strengths associated with being autistic and highlights that we need to be more aware of the strengths that autistic individuals may have as well to optimize their opportunities to achieve their goals or contribute to society.

    There also are several environmental factors that have been shown to increase the risk of autism. One of them is maternal exposure to valproate, which is an anti-epilepsy medication. There are several maternal viral infections that have been associated with autism. And two other things: the interbirth interval — how quickly after one birth a mother has another — and the age of the father. The thought on the last point is that as a man ages, their DNA repair mechanisms are maybe less active, and there are more frequent mutations in sperm.

    A key point is that all these known environmental factors act prenatally, so in most cases the tendency towards being on the spectrum is something that individuals are born with.

    CNN: To what extent has research debunked the controversial notion that vaccines can cause autism?

    Geschwind: The notion that vaccines cause autism has been entirely (disproved). There have been dozens of studies, using very different methodologies. There is absolutely no evidence that vaccines cause autism, and there’s been much more harm than good done by purveyors of that fiction.

    CNN: How do you treat autism?

    Geschwind: It is imperative to have an early diagnosis, because we know that early identification and early intervention with behavioral therapies can be effective in up to 50% of kids. Some kids will respond so well that it’s very hard to make a diagnosis of autism when they’re 9 years old if the therapy is started early enough.

    The problem is that for many autistic individuals, current therapies are not that effective. There’s a lot of work being done developing more effective cognitive behavioral therapies, figuring out which therapy is the best for which child. There’s also work being done to develop medications that can be helpful to treat certain symptoms such as injurious behavior, repetitive behavior or difficulty with changes in routines.

    My colleagues and I want to use treatment to augment and improve people’s symptoms, not change who they are fundamentally. We believe strongly in every individual’s autonomy. We also believe in personalized medicine so that it’s not one-size-fits-all. There will be some patients in whom we’re trying to correct a severe genetic mutation that has profound consequences, and there’ll be others that need only a handful of accommodations, just like we provide for folks who need wheelchairs.

    CNN: What will your research focus on next?

    Geschwind: There are two basic frontiers in my research. One recognizes that most of the work in neuropsychiatric disorders and autism has been done in primarily White European populations and focuses on a pressing need to be studying diverse populations. About seven or eight years ago, I started working with African American communities because certain aspects of genetics are population-specific, and we as researchers really need to understand that.

    The frontier that is crosscutting across all of this is we need to be able to move from genetics in a population to genetics in an individual, so that by looking at somebody’s genetic makeup, we can understand the mechanism of their autism. This is precision medicine.

    My work is trying to understand how specific genetic variants, how specific mutations, impact brain development to eventually lead to the symptoms of autism. If my colleagues and I can understand that mechanism, just like we can understand the genetic mechanism in cancer, we can find a drug to target that and improve those symptoms over time.

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    Why we have nightmares and how to stop them | CNN

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    Sign up for CNN’s Sleep, But Better newsletter series. Our seven-part guide has helpful hints to achieve better sleep.



    CNN
     — 

    We leave behind our fears of monsters under the bed as we say goodbye to our childhoods, but one can follow us into adulthood and loom over our heads.

    Nightmares are more common in childhood, but anywhere from 50% to 85% of adults report having occasional nightmares.

    Almost everyone can experience nightmares.

    “Dreams do usually incorporate things that happened during the day, leading some researchers to hypothesize that dreams and rapid eye movement sleep is essential for memory consolidation and cognitive rejuvenation,” said Joshua Tal, a sleep and health psychologist based in Manhattan.

    “Nightmares are the mind’s attempts at making sense of these events, by replaying them in images during sleep.”

    Nightmares are what the American Academy of Sleep Medicine call “vivid, realistic and disturbing dreams typically involving threats to survival or security, which often evoke emotions of anxiety, fear or terror.”

    If someone has frequent nightmares — more than once or twice weekly — that cause distress or impairment at work or among people, he or she might have nightmare disorder. Treatments include medications and behavioral therapies.

    Addressing frequent nightmares is important since they have also been linked to insomnia, depression and suicidal behavior. Since nightmares can also cause sleep deprivation, they are linked to heart disease and obesity as well.

    Trying out these 10 steps could help you ease your nightmares and improve your sleep and quality of life.

    Nightmares occur during rapid eye movement sleep, the phase during which our muscles relax and we dream. Waking up during REM sleep enables recollection of the dream and resulting distress, said Jennifer Martin, a professor of medicine at the David Geffen School of Medicine at the University of California, Los Angeles, and member of the American Academy of Sleep Medicine’s board of directors.

    “One of the most effective ways to treat nightmare problems in adults is actually to get them sleeping more soundly (so) they wake up less often,” Martin said.

    A healthy sleep routine begets sound sleep. Develop one by exercising, setting regular sleep and waking times, ensuring your room is dark and cool, avoiding stimulating beverages after midafternoon and engaging in relaxing activities.

    Alcoholic beverages can induce restlessness and awakenings throughout the night — potentially helping you remember nightmares, Martin said.

    “A lot of people use alcohol as a way to wind down and feel sleepy at the end of the day, but it’s really not the right solution,” she added. Instead, try herbal teas and other beverages conducive to sleep. If drinking was the only part of your relaxation routine, chat with your partner or read instead.

    One drink more than three hours before bedtime is OK, Martin said. Just pay attention to whether it causes a post-dinner nap and alertness at bedtime, and eliminate that drink if it does.

    Avoid snacking before bed to prevent spiking your metabolism and activating your brain.

    Snacking can boost metabolism, which causes your brain to be more active and could lead to nightmares, according to the National Sleep Foundation.

    While some people sleep better after eating a light snack, you should stop eating two to three hours before bedtime. If you notice that you have nightmares afterward, try avoiding nighttime snacking or heavier meals before bed.

    Some medications can prompt nightmares by interrupting REM sleep.

    “If people can identify that their nightmares either started or increased when they had a change in their medication, that’s definitely a reason to talk to their doctor” about their medication schedule or alternatives, Martin said.

    Melatonin, while a popular sleep aid, influences our circadian rhythm that regulates REM sleep, and can lead to more or fewer nightmares. If you want to take melatonin for better sleep, work with a sleep specialist to ensure you’re taking it at the right time and not compounding the problem, Martin said.

    Calming activities can deactivate your fight-or-flight response and trigger your relaxation system.

    Progressive muscle relaxation — tensing muscle groups as you inhale and relaxing them as you exhale — has been effective for reducing nightmares.

    “Nightmares activate the sympathetic nervous system, the ‘fight or flight system,’ the body’s natural response to imminent danger,” said Tal via email.

    “The body also has an innate relaxation system: the parasympathetic nervous system, aka the ‘rest and digest’ system.” Progressive muscle relaxation and other relaxation activities can help activate that system.

    Journaling can help you release your anxieties.

    Write down your worries to get them all out ahead of time, lest they rear their disquieting heads at night. Journaling can be helpful for alleviating nightmares and stress in general, Tal said.

    Images from any exciting or disturbing content you watched before bed can appear in your dreams.

    Since our nighttime observations can appear during sleep, “spend some energy engaging with things that are more emotionally neutral or even positive” before bedtime, Martin suggested.

    During the pandemic, our everyday lives are looking pretty scary, too. “Reading the news media and then hopping into bed is more likely to trigger disturbing and upsetting dreams than looking through pictures from your last vacation with your family,” she added.

    Imagery rehearsal therapy is effective “when the chronic nightmares are showing similar themes and patterns,” Tal said.

    Since nightmares can be learned behavior for the brain, this practice involves writing down in detail the narrative elements of the dream. Then rewrite the dream so that it ends positively. Just before falling asleep, set the intention to re-dream by saying aloud, “If or when I have the beginnings of the same bad dream, I will be able to instead have this much better dream with a positive outcome.”

    “By practicing a rewrite during the daytime, you increase your chances of having them at night while you’re sleeping instead of your nightmare,” Tal said.

    Silence is key in a sleep routine, but “for people who either don’t like it to be completely quiet or who are awakened by noises they can’t control during the night,” background noise “is a good strategy,” Martin said.

    Try a fan or a white noise machine or app for several consecutive nights to help your brain adapt, she added.

    If nothing works and you’re still having nightmares, talk with a therapist or sleep specialist.

    “Nightmares might be a sign of a larger issue, such as PTSD or a mood disorder,” Tal said. “It is possible to treat the nightmares without treating the underlying disorder, but it may also be helpful to treat both the symptom and the disorder.

    “There has been great progress on psychological treatments for nightmares, insomnia, anxiety and mood disorders,” Tal added. “Do not be afraid to ask for help; psychotherapy works and it is often short term and accessible.”

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    Clinics and doctors brace for more restrictions on women’s health care after court ruling on abortion drug | CNN

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    CNN
     — 

    Less than a year after the US Supreme Court ended legal protection for abortions nationwide, clinics that provide reproductive health care across the United States are bracing for more restrictions on the care they provide to women.

    If a judge’s ruling takes effect Friday, it may soon be illegal for doctors to prescribe mifepristone, the first in a two-drug regimen that can help women terminate a pregnancy at home – and that has other uses.

    At Northeast Ohio Women’s Center, staffers are calling patients who expected to get medication abortions next week, telling them to change their plans.

    “They’re scrambling to change their schedules to get in to see us earlier,” said Dr. David Burkons, the physician who runs the clinics.

    About half of abortions in the US use mifepristone, which is sold under the brand name Mifeprex.

    Mifeprex blocks the hormone progesterone, which effectively stops a pregnancy from continuing. For an abortion, women take mifepristone first, followed one or two days later by misoprostol, a drug that causes the uterus to contract, cramp and bleed, similar to a heavy period. It empties out the uterus, ending the pregnancy. It can be used up to 10 weeks of pregnancy.

    But the uses of mifepristone go beyond abortion.

    The drug helps soften and open the cervix, the neck of the uterus, and doctors depend on it to help when women are having a miscarriage and when a pregnancy needs to be terminated quickly if the life of the mother is at stake.

    In certain situations, when a pregnancy has become too risky, time is of the essence, says Dr. Alison Edelman, who directs the division of Complex Family Planning at Oregon Health and Sciences University.

    “The more expediently that we can have somebody not be pregnant, the better, and mifepristone helps us speed that process up and make it safer for patients,” she said.

    Doctors also use mifepristone before procedures in which they need to go into the uterus, such as to remove bleeding polyps. Studies have shown that the drug helps reduce the amount of force needed to open the cervix and reduces the amount of blood loss associated with the procedure.

    Studies also show that mifepristone has moderate to strong benefits for inducing labor and treating uterine fibroids and endometriosis, sometimes helping avoid surgery, according to the American Society of Health Systems Pharmacists.

    It can be used to prevent bleeding between periods and to control hyperstimulation of the ovaries during in-vitro fertilization, the society said in a statement.

    Doctors say they still have other ways to treat those problems, but when considering the needs of individual patients, they will be missing a valuable tool.

    “We have our gold standard of what we provide – the safest, most effective regimen – and then if it’s not available, we use the next best one. And that’s what we would be left with,” Edelman said.

    Mifepristone has been approved by the US Food and Drug Administration for 23 years, and it has been used by over 5 million women in the United States. FDA data shows that less than 1% of women who take it have significant adverse events. A CNN analysis of FDA data found that mifepristone was even less risky than some other common medications, including Viagra and penicillin.

    Medication abortions have become an increasingly important option for women in states that restricted abortion access after the Supreme Court’s ruling last year that ended legal protections for abortions in every state. They are also sometimes the only kind of abortion many women can get in rural areas that have lost abortion providers.

    This ease of access has also made the medication regimen a target for abortion opponents.

    “They want to see a national ban, and this is in fact what they are going for in this case,” said Kristen Moore, director of the EMAA Project, a nonprofit that is seeking to make it easier to get abortion medications in the US.

    What will happen next is far from settled. Appeals have been filed to stop the ruling in Texas from taking hold, and higher courts will have to weigh in.

    Even if the court does take mifepristone off the market in the US, doctors say, they will still be able to provide medication abortions using misoprostol alone.

    In fact, some abortion providers have been planning on using misoprostol by itself in case mifepristone is isn’t available.

    Carafem, which provides telehealth abortion care, has been offering a misoprostol-only regimen since the Covid-19 pandemic began, Chief Operating Officer Melissa Grant says.

    “In 2020, we started to use misoprostol alone as an option,” she said. Workers have since been tweaking the regimen and gathering data.

    “We now feel confident that, even though we would much prefer to use both, that we can use misoprostol alone effectively and are ready to switch gears to have a higher percentage of our clients or even 100% of our colleagues use that option if necessary,” Grant said.

    Still, some providers said it’s not ideal.

    The misoprostol-only regimen is slightly less effective than the one that uses both drugs, and it causes more cramping and bleeding, which can mean more complications.

    “We’re more likely to see failures and therefore more likely to need surgical intervention after misoprostol alone,” said Dr. Erika Werner, chair of the Department of Obstetrics and Gynecology at Tufts Medical Center.

    Still, doctors want women to know that medication abortions and miscarriage care will still be available even if mifepristone isn’t. And they hope that higher courts will intervene to keep this medication on pharmacy shelves.

    “The clinicians would have to use these other options instead of choosing based on their own expertise, knowledge and judgment when rendering such care,” Dr. Iffath Hoskins, president of the American Congress of Obstetricians and Gynecologists, said Monday. “Frankly, as a clinician, I do not want to be in that position.”

    Correction: This story has been updated to include the correct name of Tufts Medical Center.

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    #Clinics #doctors #brace #restrictions #womens #health #care #court #ruling #abortion #drug #CNN

    Concerned about the courts, some states and universities are stockpiling abortion drugs | CNN

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    CNN
     — 

    With an eye on the courts, a growing number of Democratic-led states are stockpiling the pills that can be used for a medication abortion, the most common form of the procedure in the US.

    The officials want to be prepared, in case US District Judge Matthew Kacsmaryk’s decision to suspend the US Food and Drug Administration’s approval of mifepristone goes through, so medication abortions would still be available in their states for some period of time. But they’re taking different approaches to the idea.

    New York Gov. Kathy Hochul announced Tuesday that her state’s Department of Health would buy 150,000 doses of misoprostol, the other of the two drugs typically used in a medication abortion.

    Misoprostol can be used off-label for an abortion, without mifepristone, but patients often have to use more of it. It would not be covered by the court case, and if Kacsmaryk’s decision stands, the New York City’s Health Department tweeted, it will change to using this medication only.

    “Medication abortion continues to be available at our Sexual Health Clinics and NYC Health + Hospitals locations. Should mifepristone become unavailable, we will continue to make medication abortion accessible to all in NYC by shifting to a misoprostol-only treatment regimen,” the tweet said.

    The state says the 150,000 doses should represent a five-year supply of pills.

    “Anti-choice extremists have shown that they are not stopping at overturning Roe, and they are working to entirely dismantle our country’s reproductive health care system, including medication abortion and contraception,” Hochul said. “New York will always be a safe harbor for abortion care, and I am taking action to protect abortion access in our State and continue to lead the nation in defending the right to reproductive autonomy.”

    California is also stocking up on misoprostol.

    “While California still believes Mifepristone is central to the preferred regimen for medication abortion, the State negotiated and purchased an emergency stockpile of Misoprostol in anticipation of Friday’s ruling by far-right federal judge Matthew Kacsmaryk to ensure that California remains a safe haven for safe, affordable, and accessible reproductive care,” Gov. Gavin Newsom’s office said in a release Monday.

    California plans to purchase up to 2 million pills through CalRx, a state initiative set up to make drugs more affordable.

    The governor’s office said the state now has more than 250,000 pills on hand, which it purchased for about $100,000.

    California said it shared the terms of its purchase agreement with other members of the Reproductive Freedom Alliance, a nonpartisan coalition of 21 governors who are committed to protecting reproductive rights, and who might also be interested in taking such action.

    Another member of that alliance, Washington Gov. Jay Inslee, announced last week that his state bought a three year-supply of mifepristone, the drug at the center of Kacsmaryk’s ruling.

    Inslee directed the state Department of Corrections – which has a pharmacy license and is legally able to buy medications – to buy the drug last month, he said, and the shipment was delivered March 31. The University of Washington also purchased 10,000 doses.

    Lawmakers are introducing a bill to authorize officials to distribute or sell the medication to licensed providers throughout the state.

    “This Texas lawsuit is a clear and present danger to patients and providers all across the country. Washington will not sit by idly and risk the devastating consequences of inaction,” Inslee said. “Washington is a pro-choice state, and no Texas judge will order us otherwise.”

    In the meantime, its attorney general, Bob Ferguson, is helping lead a multistate lawsuit to protect access to mifepristone.

    On Friday, the same day Kacsmaryk’s ruling came down, a federal judge in Washington ordered the US not to make any changes that would restrict access to mifepristone in the territories that brought the lawsuit: 17 states and the District of Columbia.

    On Monday, Massachusetts Gov. Maura T. Healey announced that at her request, the University of Massachusetts and health care providers have also taken action to stockpile doses of mifepristone.

    The governor’s office said last week that the university bought about 15,000 doses of mifepristone, enough to cover the commonwealth for about a year, and the pills are expected to arrive this week. Local health care providers have agreed to buy more, and the government agreed to set aside $1 million to pay for those doses.

    The Massachusetts governor also signed an executive order confirming protections for medication abortion under existing law.

    “Here in Massachusetts, we are not going to let one extremist judge in Texas turn back the clock on this proven medication and restrict access to care in our state,” Healey said. “The action we are taking today protects access to mifepristone in Massachusetts and protects patients and providers from liability. In Massachusetts, we stand for civil rights and freedom. We will always protect access to reproductive health care, including medication abortion.”

    Danco Laboratories, the manufacturer of the brand-name version of mifepristone, says that orders for the drug have increased substantially in recent months and are significantly higher than they were at this time last year.

    Demand for mifepristone is up across all types of customers, including clinics, pharmacies and individual providers, said Abby Long, Danco’s director of public affairs. But Massachusetts is the only state that has requested an especially large number of pills from the company.

    Maine Gov. Janet Mills, who called the Texas decision “reckless” and a “fundamental assault on women’s rights,” said Monday that her administration is evaluating its options, “including procuring mifepristone if needed, to protect access to medication abortion for Maine women.”

    The Connecticut governor’s office said Wednesday that it is also monitoring the situation.

    Oregon Gov. Tina Kotek’s office said in an email Wednesday that she has directed the Oregon Health Authority to “explore all available avenues for ensuring Oregon is prepared should Mifepristone become less available. That includes evaluating the supply of Mifepristone and Misoprostol and consulting with providers to better understand the potential impact on the provision of abortion and reproductive health care and what additional support might be necessary.”



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    ‘It just didn’t enter my mind to initiate sex;’ Low sex drive in men linked to chemical imbalance | CNN

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    Editor’s Note: Get inspired by a weekly roundup on living well, made simple. Sign up for CNN’s Life, But Better newsletter for information and tools designed to improve your well-being.



    CNN
     — 

    While hanging out with his college roommates, Peter (not his real name) realized he felt differently about sex than other heterosexual men.

    “I’ve never been somebody who was interested in pornography, but I’d laugh along with their jokes,” said Peter, now 44, who is British. “Of course I never mentioned that … as a man, you’d be kicked out of the herd.”

    As he developed “proper, serious relationships” with women, Peter discovered he didn’t have the sexual drive many of his partners did.

    “I would make excuses around getting tired or feeling stressed, that kind of thing,” he said. “It wasn’t an issue with attraction to my partner. It just didn’t enter my mind to initiate sex.”

    In 2021, Peter saw an ad recruiting male volunteers for a new study on hypoactive sexual desire disorder, or HSDD. Researchers planned to inject the study’s participants with kisspeptin —a naturally occurring sexual hormone — to see if it increased their sex drive. Kisspeptin plays a key role in reproduction; without adequate levels of the hormone children do not go through puberty, for example.

    In a long-term, committed relationship with a woman he says has a higher sexual appetite, Peter signed up, intrigued by the thought that a biological imbalance might help explain his behavior.

    In the week after the final session, Peter said, something amazing occurred.

    “All of a sudden, I wanted to initiate intimacy. I can only presume it was driven not by my mind remembering something, but my body wanting something,” he said. “I did initiate sex more and it improved things with my partner incredibly.”

    Experts believe HSDD affects at least 10% of women and up to 8% of men, although those numbers may be low, said Stanley Althof, a professor emeritus of psychology at Case Western Reserve University School of Medicine in Cleveland, Ohio and executive director of the Center for Marital and Sexual Health of South Florida.

    “Men are embarrassed to go to the doctor to begin with, and you’re supposed to be a macho guy,” said Althof, who was not involved in the kisspeptin study.

    “So it’s difficult for men to say, ‘Hey, I’ve got a problem with my sex drive.’ That’s why the majority of male patients I see with HSDD are sent in by their partners.”

    To be diagnosed with the disorder, a person must have no other issues that might cause a change in libido, such as erectile dysfunction or premature ejaculation.

    “Losing interest due to performance issues is common, but HSDD is its own thing,” Althof said. “It’s an absence of erotic thoughts and a lack of desire for sex that has to be present for six months. It also cannot be better explained by another disorder or other stressors: It can’t be due to depression. It can’t be due to a bad relationship. It can’t be due to taking an antidepressant.”

    One more key point: A man or woman must have clinically significant distress to have HSDD, said clinical psychologist Dr. Sheryl Kingsberg, a professor in reproductive biology and psychiatry at Case Western Reserve University, who was also not involved in the kisspeptin study.

    “Some people aren’t bothered by their lack of interest in sex, so we wouldn’t treat them for HSDD,” said Kingsberg, who is also chief of behavioral medicine at MacDonald Women’s Hospital and University Hospitals Cleveland Medical Center.

    “The women coming into my office are deeply distressed,” she said. “They tell me ‘I used to have desire but it’s gone. I could be on a desert island with no pressures, but I just don’t have the appetite. I want it back.’ Those women have HSDD.”

    Dr. Waljit Dhillo, a professor in endocrinology and metabolism at Imperial College London, has been studying the relationship between low sexual desire and the hormone kisspeptin for years, first in animals, then in people.

    Prior studies by Dhillo of healthy men with no libido problems found giving them kisspeptin boosted levels of testosterone and luteinizing hormone, which is important for gonad function.

    His newest study, published in the journal JAMA Network Open in February, enrolled 32 men with verified HSDD. Peter was one of them.

    “So many people say to themselves, ‘It’s just me. I’ve got a problem.’ But actually, HSDD may be how your brain is wired,” said Dhillo, who is a dean at the United Kingdom’s National Institute for Health and Care Research Academy in Newcastle upon Tyne.

    “The biology is telling us there’s increased activation of inhibitory areas in the brain — the same areas that tell us it’s not OK to walk around in public naked — and those areas are switching off sexual desire. How can we tackle that? We give a hormone that would naturally give you increased sexual desire, essentially hijacking the normal system.”

    The men participating in the new study visited Dhillo’s lab twice. On each occasion, they were fitted with a device to objectively measure arousal, given an injection and asked to watch pornography while their brains were scanned via functional magnetic resonance imaging (fMRI).

    Neither the subjects or the researchers knew if that day’s injection was kisspeptin or a placebo.

    “It was extraordinarily surreal, lying there with something resembling a hangman’s noose around your bits and watching a mixture of ’70s to modern-day pornographic images and videos,” Peter said. “You’d get about five or six seconds of one type of image or video, rate your arousal for the researchers, and then move on to the next.”

    Brain scans showed a significant dual effect after the kisspeptin injection, Dhillo said. Activity in the areas of the brain that inhibit behavior slowed, while areas of the brain connected to sexual interest lit up.

    “As a group, the men had a 56% higher sexual response to sexual images after the kisspeptin than the placebo,” Dhillo said. “And we found no side effects at the very, very small dose that we are using.”

    Peter noticed a difference immediately after finishing the treatments. His sex life was so robust, in fact, that it wasn’t long before his partner was pregnant with their first child.

    As published, the study did not follow the men long-term to see if the effects of kisspeptin lasted. For Peter, however, its impact has been life-changing.

    “I have found there’s been a lasting effect for me,” he said. “I do find I have a much better sexual appetite even now some years after the treatment.”

    Even the arrival of a baby boy didn’t deter his new interest in sex.

    “The cliche is when you have kids, your sex life takes a bit of a hit,” he told CNN. “But that hasn’t been the case for us. In fact, we’re pregnant with our second child, due in July.”

    While Peter had a positive long-term result, it’s too soon to say kisspeptin injections were the reason, Althof said.

    “When you hear dramatic results like Peter’s, I would be cautious in saying that is the typical outcome. While it’s wonderful that it happened for him, these fMRI studies are difficult to interpret and not conclusive,” he said.

    “Sexual desire is very complicated — I say it’s a combination of brain function, hormones and love, wine and roses,” Althof added. “This study is promising, but it needs replication in larger groups.”

    And even if future research does confirm kisspeptin’s benefits, medical treatment is not a substitution for healthy communication about sex between partners and with health care providers, Dhillo said.

    “These are society’s taboos, but actually, the more we talk about real (sexual) issues that affect real people, the more we find it’s actually quite common,” he said.”If you’re not troubled by low libido, it’s not an issue at all, but if you are troubled by it, this can lead to marital breakdown, unhappiness and reduced quality of life.”

    Study: Climate change is killing our sex drive

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    EPA proposes new regulations on toxic gas used to sterilize spices and medical equipment | CNN

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    CNN
     — 

    The US Environmental Protection Agency on Tuesday proposed a set of new restrictions on facilities that use the cancer-causing chemical ethylene oxide, a colorless, odorless gas that is used to sterilize medical devices and spices.

    The agency said the new rules, which have not been finalized, would help to reduce ethylene oxide gas that these facilities release by 80%, bringing emissions below a Clean Air Act standard for elevated cancer risk.

    Communities exposed to ethylene oxide gas have been pushing the EPA to put tighter controls on plants that use ethylene oxide gas.

    In 2018, an EPA report found that dozens of communities across the nation faced elevated cancer risks because of trace of amounts of ethylene oxide released into air as part of the sterilization process.

    The EPA issued the report on the new risks without issuing a news release, as it had done for the same report in years past. Some affected communities learned of the risk through a health assessment conducted by the Agency for Toxic Substances and Disease Registry, a division of the US Centers for Disease Control and Prevention, and media reports. A report from the EPA’s Office of the Inspector General found that some communities weren’t alerted to their risk by EPA at all.

    The elevated risk became apparent after a two-decade long review of the toxicity of ethylene oxide by scientists in EPA’s Integrated Risk Information System (IRIS) program.

    While the EPA acknowledged that ethylene oxide was more dangerous that had been previously understood, it continued to use an older set of rules to regulate facilities that released ethylene oxide as well as companies that manufacture it.

    The proposed rules aim to better align regulations on the producers and users of ethylene oxide with the cancer risk posed by the chemical. They follow a set of proposed rules issued by EPA last week that would put new controls on facilities that manufacture ethylene oxide.

    Taken together, the two sets of rules would remove 77 tons of ethylene oxide emissions a year, an 84% reduction compared with 2020 levels, EPA Deputy Administrator Janet McCabe said in a call with reporters on Tuesday.

    Environmental watchdog groups applauded the proposed restrictions, but noted that they don’t go far enough to protect vulnerable communities, where residents are often low-income and disproportionately people of color.

    “These regulations are long overdue, by almost a decade. I’m relieved and pleased that the EPA has finally issued proposed standards that are based on their own scientists’ recommendations on an updated, higher cancer risk value. If enacted, these updated regulations would reduce emissions in fenceline communities,” said Darya Minovi, a senior researcher scientist at the Union of Concerned Scientists.

    “When the EPA issues the final rule, they should throw the net wider. The standard should cover a larger range of facilities to include off-site warehouses that often store recently sterilized equipment that continue to release ethylene oxide, but aren’t regulated for their air emissions.”

    Minovi also said the EPA should require fenceline monitors – devices that constantly read the air outside of facilities to make sure that toxic gas isn’t drifting into neighborhoods.

    Jaime Rukstales, a member of the Illinois grassroots advocacy group Stop EtO in Lake County – one of the communities impacted by ethylene oxide pollution – says the EPA needs to impose tougher restrictions on “all types of facilities that impact the health of our communities … including sterilizers, manufacturers and warehouses near our homes, schools and businesses.”

    Some off-site warehouses used to store newly sterilized products have registered high levels of ethylene oxide due to off-gassing of the products.

    Meanwhile, chemical manufacturers sued the EPA in February over its updated hazard assessment for ethylene oxide. The industry wants the agency to use a less protective standard developed by the Texas Commission on Environmental Quality.

    AdvaMed, a group that lobbies for the interests of medical device manufacturers, warned that more regulations could pose problems for patients.

    “If new EPA regulations force sterilization facilities to close, patients could face treatment delays as sterile technology supplies, such as pacemakers and surgical equipment, fall short,” Scott Whitaker, president and CEO of AdvaMed, said in a comment posted on the group’s website.

    The EPA said some commercial sterilizers have already made the planned changes.

    “Many sterilization and health care facilities are already taking the steps outlined in the proposal and have seen emissions drop significantly,” McCabe said.

    Most facilities have taken action to control ethylene oxide blown out of sterilization chambers through exhaust vents known as “back vents” but only 25% to 33% of sterilizers are controlling so-called fugitive emissions, ethylene oxide that escapes or leaks into room air, said Jonathan Witt, an environmental engineer and technical lead on EPA’s review of the National Emissions Standards for Hazardous Air Pollutants.

    “So we think it’s a good sizable chunk of the industry, but still a little ways to go,” Witt said on a call with reporters.

    If the rules go into effect, sterilizers would have 18 months to make the changes, which the EPA said is an accelerated time frame under the Clean Air Act.

    AdvaMed’s Whitaker says that’s not enough time.

    “It could take many months for abatement equipment to arrive. Supply chains and manufacturing are still recovering from the pandemic,” he noted in the statement.

    In issuing the proposed rules, the EPA said it aimed to strike a balance between lowing cancer risks for impacted communities and workers who use ethylene oxide while preserving “critical sterilization capabilities.”

    The proposed rules would apply to 86 commercial sterilization facilities in the United States that use ethylene oxide gas to fumigate spices and medical devices.

    The EPA says 20 billion medical devices – mostly single-use, disposable items used in health care such as catheters, gloves and surgical gowns – are sterilized using ethylene oxide.

    The US Food and Drug Administration is actively exploring alternatives to the use of the gas, the EPA said on Tuesday, but some devices still can’t be sterilized any other way.

    In proposing the new rules, EPA said its new analysis found that exposure to ethylene oxide, or EtO, on the job significantly increased cancer risks for workers in sterilization facilities and those who apply ethylene oxide in health care facilities.

    “Now, a new EPA analysis shows that there may also be significant risks to workers who handle [ethylene oxide] and people who live, work or go to school near places where EtO is used in sterilization. And failing to take action to address these risks is simply unacceptable,” EPA Administrator Janet McCabe said on a call with reporters.

    The additional lifetime cancer risk for a worker exposed to ethylene oxide for eight hours a day, 240 days a year for 35 years was between 1 in 10 and 1 in 36 for workers in sterilization facilities; and between 1 in 12 and 1 in 25 for workers exposed to ethylene oxide in health care facilities.

    To help lower those risks, the proposed rules require greater use of personal protective equipment for workers and new controls to decrease the amount of ethylene oxide in indoor air.

    Whitaker from AdvaMed, the medical device industry group, said the cancer risk for employees exposed to ethylene oxide on the job is overstated and disregards “the strong employee protections already in practice.”

    Companies will also be required to use new real-time monitoring methods to confirm that these pollution controls are working inside facilities. These controls can measure ethylene oxide in indoor air down to 10 parts per billion. If ethylene oxide levels climb above this threshold, everyone in the workplace would be required to wear protective equipment.

    They will also lower the amount of ethylene oxide that can be used for each sterilization cycle. The EPA is proposing to limit the application rate for ethylene oxide to no more than 500 milligrams per liter of air.

    The rules would eliminate some niche uses of ethylene oxide where alternatives exist, including its use in museums, archival settings, beekeeping, some cosmetics, and in musical instruments.

    The EPA will take public comment on the new rules for 60 days. The agency will also host a virtual public webinar on May 1 to discuss its proposed rules and new risk assessment.

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